Kidney Cancer Clinical Trial

A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)

Summary

This study will compare the efficacy and safety of two doses of belzutifan in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy.

The primary hypothesis is that the higher dose of belzutifan is superior to the standard dose in terms of objective response rate (ORR).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has a histologically confirmed diagnosis of locally advanced/metastatic RCC with clear cell component
Has measurable disease per RECIST 1.1 as assessed by BICR
Can submit an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Has experienced disease progression on or after systemic treatment with an anti-programmed cell death 1 (PD-1)/Ligand 1 (L1) therapy for locally advanced or metastatic RCC. The anti-PD-1/L1 therapy may be monotherapy or in combination with other agent(s) such as anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) or vascular endothelial growth factor (VEGF) targeted- tyrosine kinase inhibitor (TKI). The immediately preceding line of treatment has to have been an anti-PD-1/L1 therapy
Has received no more than 3 prior systemic regimens for locally advanced or metastatic RCC
Has received only 1 prior anti-PD-1/L1 therapy for locally advanced or metastatic RCC
Has recovered from all AEs due to previous therapies to ≤Grade 1 or baseline, with the exception of ≤Grade 2 neuropathy or endocrine-related AEs ≤Grade 2 requiring treatment or hormone replacement
Has a Karnofsky performance status (KPS) score of at least 70% assessed within 10 days prior to the first dose of study intervention
A male participant is eligible to participate if he is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 7 days after the last dose of study intervention
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a (woman of childbearing potential) WOCBP or a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 24 hours before the first dose of study intervention

Exclusion Criteria:

Has hypoxia (a pulse oximeter reading <92% at rest), requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ [e.g., breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction ≤6 months from Day 1 of study drug administration or New York Heart Association Class III or IV congestive heart failure
Has moderate to severe hepatic impairment (Child-Pugh B or C)
Has received colony-stimulating factors (eg, granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], or recombinant erythropoietin [EPO]) ≤28 days prior to the first dose of study intervention
Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study
Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, malabsorption)
Has known hypersensitivity or allergy to the active pharmaceutical ingredient or any component of the study intervention (belzutifan) formulations
Has received prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2α inhibitor
Has received any type of small molecule kinase inhibitor (including investigational kinase inhibitor) ≤2 weeks before randomization
Has received any type of systemic anticancer antibody (including investigational antibody) ≤4 weeks before randomization
Has received prior radiotherapy ≤2 weeks prior to first dose of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids
Has had major surgery ≤3 weeks prior to first dose of study intervention
Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (eg, bosentan, efavirenz, modafinil) inducers of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
Is currently participating in a study of an investigational agent or is currently using an investigational device
Has an active infection requiring systemic therapy
Has active tuberculosis (TB)
Has a diagnosis of immunodeficiency
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of hepatitis B (HBV) or known active hepatitis C (HCV) infection
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not the best interest of the participant to participate, in the opinion of the treating investigator

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

154

Study ID:

NCT04489771

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 47 Locations for this study

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Georgetown University Medical Center ( Site 0002)
Washington District of Columbia, 20007, United States
Univ of Miami- Sylvester Comprehensive Cancer Center ( Site 0023)
Miami Florida, 33136, United States
Norton Cancer Institute - St. Matthews ( Site 0025)
Louisville Kentucky, 40207, United States
Weinberg Cancer Institute at Franklin Square ( Site 0007)
Baltimore Maryland, 21237, United States
Cancer Partners of Nebraska ( Site 0003)
Lincoln Nebraska, 68510, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0012)
Omaha Nebraska, 68130, United States
New York Oncology Hematology P.C ( Site 0028)
Albany New York, 12206, United States
Roswell Park Cancer Institute ( Site 0038)
Buffalo New York, 14263, United States
Fox Chase Cancer Center ( Site 0026)
Philadelphia Pennsylvania, 19111, United States
Sanford Cancer Center Oncology Clinic ( Site 0031)
Sioux Falls South Dakota, 57104, United States
UT West Cancer Center ( Site 0032)
Germantown Tennessee, 38138, United States
Urology Associates ( Site 0015)
Nashville Tennessee, 37209, United States
University of Texas Southwestern Medical Center at Dallas ( Site 0004)
Dallas Texas, 75390, United States
Baylor Scott & White Medical Center - Temple ( Site 0013)
Temple Texas, 76508, United States
Huntsman Cancer Institute ( Site 0037)
Salt Lake City Utah, 84112, United States
Inova Schar Cancer Institute ( Site 0001)
Fairfax Virginia, 22031, United States
Blue Ridge Cancer Care - Roanoke ( Site 0017)
Roanoke Virginia, 24014, United States
Kadlec Clinic Hematology and Oncology ( Site 0008)
Kennewick Washington, 99336, United States
Macquarie University ( Site 1007)
Macquarie University New South Wales, 2109, Australia
Eastern Health - Box Hill Hospital ( Site 1003)
Box Hill Victoria, 3128, Australia
Peninsula Health Frankston Hospital ( Site 1001)
Frankston Victoria, 3199, Australia
GZA Sint Augustinus ( Site 2003)
Wilrijk Antwerpen, 2610, Belgium
Grand Hopital de Charleroi ( Site 2005)
Charleroi Hainaut, 6000, Belgium
CHU de Liege ( Site 2002)
Liège Liege, 4000, Belgium
UZ Gent ( Site 2004)
Gent Oost-Vlaanderen, 9000, Belgium
UZ Leuven ( Site 2001)
Leuven Vlaams-Brabant, 3000, Belgium
General Hospital of Athens "Alexandra" ( Site 1102)
Athens Attiki, 115 2, Greece
Athens University Hospital ATTIKON ( Site 1100)
Chaidari Attiki, 12 46, Greece
University General Hospital of Larissa ( Site 1101)
Larissa Thessalia, 411 1, Greece
Cork University Hospital ( Site 9053)
Cork , T12 D, Ireland
Tallaght University Hospital ( Site 9051)
Dublin , D24 N, Ireland
Soroka Medical Center ( Site 4004)
Beer Sheva , 84101, Israel
Rambam Medical Center ( Site 4001)
Haifa , 31096, Israel
Rabin Medical Center ( Site 4002)
Petach Tikva , 49414, Israel
Sourasky Medical Center ( Site 4003)
Tel Aviv , 64239, Israel
Maastricht Universitair Medisch Centrum - MUMC ( Site 5001)
Maastricht Limburg, 6202A, Netherlands
Antoni van Leeuwenhoek Ziekenhuis ( Site 5003)
Amsterdam Noord-Holland, 1066 , Netherlands
Isala klinieken ( Site 5002)
Zwolle Overijssel, 8025 , Netherlands
Erasmus MC ( Site 5000)
Rotterdam Zuid-Holland, 3015 , Netherlands
Universitair Medisch Centrum Utrecht ( Site 5004)
Utrecht , 3584 , Netherlands
Federal state budgetary institution Russian Research Centre of radiology and nuclear medicine ( Site
Moscow Moskva, 11799, Russian Federation
City Clinical Oncology Hospital No. 1 ( Site 6004)
Moscow Moskva, 12909, Russian Federation
Russian Scientific Center of Radiology and Surgical Technologies ( Site 6001)
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Clinical Research Center of specialized types medical care-Oncology ( Site 6002)
Saint-Petersburg Sankt-Peterburg, 19775, Russian Federation
Royal Free London NHS Foundation Trust ( Site 9003)
London England, NW3 2, United Kingdom
Imperial College Healthcare NHS Trust ( Site 9004)
London London, City Of, W6 8R, United Kingdom
Churchill Hospital ( Site 9000)
Oxford Oxfordshire, OX3 7, United Kingdom
Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 9001)
Nottingham , NG5 1, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

154

Study ID:

NCT04489771

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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